Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT03785535
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.', 'timeFrame': '3 weeks', 'description': 'Change on brain activity rated using functional MRI measures of functional connectivity'}, {'measure': 'Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used.', 'timeFrame': '3 weeks', 'description': 'Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation'}], 'secondaryOutcomes': [{'measure': 'Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used.', 'timeFrame': '3 weeks', 'description': 'Change on brain activity rated using functional MRI measures of brain activation in response to non-nociceptive stimulation'}, {'measure': 'Measured fibromyalgia symptoms using a 101-point numerical rating scale.', 'timeFrame': '3 weeks', 'description': 'Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales.'}, {'measure': 'Tolerability rated using a numerical rating scale ranging from 0 to 100 points.', 'timeFrame': '3 weeks', 'description': 'Tolerability index (0-100).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of low-intensity and prolonged vibrotactile sensory stimulation on brain activity and functional connectivity in fibromyalgia patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Care Res 2010;62:600-10).\n2. Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)\n3. Diagnoses established by an expert on fibromyalgia.\n4. Stable treatment of chronic use.\n5. Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.\n\nExclusion Criteria:\n\n1. Generalized inflammatory articular or rheumatic disease.\n2. Severe, non-stable medical, endocrinological or neurological disorder.\n3. Psychotic disorder or drug abuse.'}, 'identificationModule': {'nctId': 'NCT03785535', 'briefTitle': 'Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Neurovoxel SLP'}, 'officialTitle': 'Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients', 'orgStudyIdInfo': {'id': 'PSI2017-83777-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Actual treatment', 'description': 'Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (2-90 Hz), low intensity and long daily duration (3h).', 'interventionNames': ['Device: Vibrotactile stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Sham treatment will be applied using identical instruments and with power and duration programmed identically. However, in this case, the output will not be the signal activating the vibration motors, but rather an electrical signal turning on an incorporated pilot light indicating that the (simulated) treatment was operating', 'interventionNames': ['Device: Vibrotactile stimulation']}], 'interventions': [{'name': 'Vibrotactile stimulation', 'type': 'DEVICE', 'description': 'The active treatment will involve whole-body sensory stimulation with mechanical stimuli of vibrotactile (pallesthetic) type at a relatively high rate, low intensity and long duration administered at sleep time (a total daily duration of 3 h distributed within a period of 2 h at bedtime and 1 h prior to getting up). The intensity will be 30% of power at bedtime and 45% prior to getting up.', 'armGroupLabels': ['Actual treatment', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurovoxel SLP', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jesus Pujol', 'investigatorAffiliation': 'Neurovoxel SLP'}}}}